Trial Outcomes & Findings for Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults. (NCT NCT04321460)

Last Updated: 2022-03-14

Results Overview

Diarrhea is defined as loose or watery stool (Type 5-7 according to Bristol Stool Form Scale (BSFS)), three times a day (frequent bowel movements with formed stool is not considered as diarrhea) in accordance with WHO criteria; based on the diary data (BSFS) and confirmation of AAD by the investigator. BSFS scale includes Types 1 to 7 where Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhea. AAD (antibiotic-associated diarrhea) is defined as diarrhea associated with the antibiotic use caused by C. difficile or of otherwise not identified etiology, upon analysis of stool samples and differential diagnostics according to investigator's judgment. Diarrhea was assessed in a diary.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

520 participants

Primary outcome timeframe

14 days

Results posted on

2022-03-14

Participant Flow

Participants were enrolled from 15 sites in the Russian Federation.

Participants were randomized in 1:1 ratio to two arms (Treatment and Placebo).

Participant milestones

Participant milestones
Measure	LRG-002 LRG-002 once daily for 14 days	Placebo Placebo once daily for 14 days
Overall Study STARTED	260	260
Overall Study Intention to Treat (ITT) Population	260	260
Overall Study Per-protocol (PP) Population	252	248
Overall Study COMPLETED	259	259
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LRG-002 LRG-002 once daily for 14 days	Placebo Placebo once daily for 14 days
Overall Study Participants who had no defecation or no data about it	1	1

Baseline Characteristics

Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LRG-002 n=260 Participants LRG-002 once daily for 14 days	Placebo n=260 Participants Placebo once daily for 14 days	Total n=520 Participants Total of all reporting groups
Age, Continuous	40.62 Years STANDARD_DEVIATION 12.93 • n=5 Participants	41.65 Years STANDARD_DEVIATION 12.74 • n=7 Participants	41.13 Years STANDARD_DEVIATION 12.83 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	167 Participants n=7 Participants	309 Participants n=5 Participants
Sex: Female, Male Male	118 Participants n=5 Participants	93 Participants n=7 Participants	211 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	259 Participants n=5 Participants	259 Participants n=7 Participants	518 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: The per protocol (PP) population included all randomized participants who completed participation in the study in accordance with the protocol (have completed the prescribed period of treatment and follow-up without significant deviations from the protocol)

Outcome measures

Outcome measures
Measure	LRG-002 n=252 Participants LRG-002 once daily for 14 days	Placebo n=248 Participants Placebo once daily for 14 days
Number of Participants With the Occurrence of Antibiotic-associated Diarrhea (AAD) - Per Protocol (PP) Population	4 Participants	17 Participants

PRIMARY outcome

Timeframe: 14 days

Population: The intention-to-treat (ITT) population included all randomized participants who received at least one dose of the investigational medicinal product/placebo and have completed at least one visit aimed at the evaluation of efficacy parameters (i.e., at least all the procedures of Visit 1)

Outcome measures

Outcome measures
Measure	LRG-002 n=260 Participants LRG-002 once daily for 14 days	Placebo n=260 Participants Placebo once daily for 14 days
Number of Participants With the Occurrence of Antibiotic-associated Diarrhea (AAD) - Intention to Treat (ITT) Population	5 Participants	22 Participants

SECONDARY outcome

Timeframe: 14 days

Bowel movements were assessed based on the data of patient's diary

Outcome measures

Outcome measures
Measure	LRG-002 n=259 Participants LRG-002 once daily for 14 days	Placebo n=259 Participants Placebo once daily for 14 days
Mean Number of Bowel Movements Per Day	1.54 Number of bowel movements per day Standard Deviation 0.64	1.76 Number of bowel movements per day Standard Deviation 0.72

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	LRG-002 n=260 Participants LRG-002 once daily for 14 days	Placebo n=260 Participants Placebo once daily for 14 days
Number of Participants With the Occurrence of Any Diarrhea	6 Participants	23 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: The intention-to-treat (ITT) population included all participants with available data, who received any study drug and had Antibiotic-associated diarrhea (AAD)

Outcome measures

Outcome measures
Measure	LRG-002 n=5 Participants LRG-002 once daily for 14 days	Placebo n=22 Participants Placebo once daily for 14 days
Number of Participants With the Occurrence of C. Difficile-associated Antibiotic-associated Diarrhea (AAD)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: The intention-to-treat (ITT) population included all participants with available data, who received any study drug and had Antibiotic-associated diarrhea (AAD)

Incidence of non-C. difficile-associated AAD assessed based on the data of stool analysis

Outcome measures

Outcome measures
Measure	LRG-002 n=5 Participants LRG-002 once daily for 14 days	Placebo n=22 Participants Placebo once daily for 14 days
Number of Participants With the Occurrence of Non-C. Difficile-associated AAD	5 Participants	21 Participants

SECONDARY outcome

Timeframe: 14 days

Population: The intention-to-treat (ITT) population included all participants with available data, who received any study drug and had Antibiotic-associated diarrhea (AAD)

AAD is defined as diarrhea associated with the antibiotic use caused by C. difficile or of otherwise not identified etiology, upon analysis of stool samples and differential diagnostics according to investigator's judgment.The duration of AAD was the time from the onset of AAD to the normalization of stool form according to Bristol Stool Scale (types 1, 2, 3 and 4 where Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid) and the presence of normal stool within 48 hours was assessed based on the data of patient's diary.

Outcome measures

Outcome measures
Measure	LRG-002 n=5 Participants LRG-002 once daily for 14 days	Placebo n=22 Participants Placebo once daily for 14 days
Mean Duration of Antibiotic-associated Diarrhea (AAD)	5.4 Days Standard Deviation 2.3	6.23 Days Standard Deviation 3.72

SECONDARY outcome

Timeframe: 14 days

Population: The intention-to-treat (ITT) population included all participants with available data, who received any study drug and had incidence of any diarrhea

Duration of any diarrhea is defined as the time from the onset of diarrhea to the normalization of stool shape according to the Bristol Stool Form Scale (BSFS) (Types 1, 2, 3, and 4) and the presence of normal stool for 48 hours). BSFS scale includes Types 1 to 7 where Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhea.

Outcome measures

Outcome measures
Measure	LRG-002 n=6 Participants LRG-002 once daily for 14 days	Placebo n=23 Participants Placebo once daily for 14 days
Mean Duration of Any Diarrhea	5 Days Standard Deviation 2.28	6.13 Days Standard Deviation 3.66

SECONDARY outcome

Timeframe: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14

Population: The intention-to-treat (ITT) population included participants with available Day 1 assessment data

Individual changes in the stool consistency were classified as improved / unchanged / worsened. The calculations were conducted as follows: 1. if more than 1 observation was available for a specific day, the maximum score was taken; 2. each subsequent day was compared to Day 1 according to the following rules: * variations within 3-4 points, 1-2 points, or 5-7 points were qualified as "unchanged"; * transfer from 1-2 points or 5-7 points to 3-4 points, as well as transfer from 5-7 points to 1-2 points were qualified as "improved"; * transfer from 3-4 points to 1-2 points or 5-7 points, as well as transfer from 1-2 points to 5-7 points were qualified as "worsened". Score interpretation: 3. 1, 2 - hard stool (constipation) 4. 3, 4 - normal value 5. 5, 6, 7 - loose stool

Outcome measures

Outcome measures
Measure	LRG-002 n=206 Participants LRG-002 once daily for 14 days	Placebo n=214 Participants Placebo once daily for 14 days
Change in Stool Consistency Day 2 Change in the stool consistency as compared to Day 1 · improved	78 Participants	56 Participants
Change in Stool Consistency Day 2 Change in the stool consistency as compared to Day 1 · unchanged	94 Participants	124 Participants
Change in Stool Consistency Day 2 Change in the stool consistency as compared to Day 1 · worsened	27 Participants	27 Participants
Change in Stool Consistency Day 2 Change in the stool consistency as compared to Day 1 · no data available	7 Participants	7 Participants
Change in Stool Consistency Day 3 Change in the stool consistency as compared to Day 1 · improved	79 Participants	60 Participants
Change in Stool Consistency Day 3 Change in the stool consistency as compared to Day 1 · unchanged	96 Participants	118 Participants
Change in Stool Consistency Day 3 Change in the stool consistency as compared to Day 1 · worsened	26 Participants	33 Participants
Change in Stool Consistency Day 3 Change in the stool consistency as compared to Day 1 · no data available	5 Participants	3 Participants
Change in Stool Consistency Day 4 Change in the stool consistency as compared to Day 1 · improved	83 Participants	62 Participants
Change in Stool Consistency Day 4 Change in the stool consistency as compared to Day 1 · unchanged	95 Participants	122 Participants
Change in Stool Consistency Day 4 Change in the stool consistency as compared to Day 1 · worsened	25 Participants	26 Participants
Change in Stool Consistency Day 4 Change in the stool consistency as compared to Day 1 · no data available	3 Participants	4 Participants
Change in Stool Consistency Day 5 Change in the stool consistency as compared to Day 1 · improved	78 Participants	59 Participants
Change in Stool Consistency Day 5 Change in the stool consistency as compared to Day 1 · unchanged	93 Participants	119 Participants
Change in Stool Consistency Day 5 Change in the stool consistency as compared to Day 1 · worsened	30 Participants	27 Participants
Change in Stool Consistency Day 5 Change in the stool consistency as compared to Day 1 · no data available	5 Participants	9 Participants
Change in Stool Consistency Day 6 Change in the stool consistency as compared to Day 1 · improved	78 Participants	59 Participants
Change in Stool Consistency Day 6 Change in the stool consistency as compared to Day 1 · unchanged	100 Participants	120 Participants
Change in Stool Consistency Day 6 Change in the stool consistency as compared to Day 1 · worsened	18 Participants	28 Participants
Change in Stool Consistency Day 6 Change in the stool consistency as compared to Day 1 · no data available	10 Participants	7 Participants
Change in Stool Consistency Day 7 Change in the stool consistency as compared to Day 1 · improved	83 Participants	60 Participants
Change in Stool Consistency Day 7 Change in the stool consistency as compared to Day 1 · unchanged	94 Participants	119 Participants
Change in Stool Consistency Day 7 Change in the stool consistency as compared to Day 1 · worsened	23 Participants	26 Participants
Change in Stool Consistency Day 7 Change in the stool consistency as compared to Day 1 · no data available	6 Participants	9 Participants
Change in Stool Consistency Day 8 Change in the stool consistency as compared to Day 1 · improved	78 Participants	61 Participants
Change in Stool Consistency Day 8 Change in the stool consistency as compared to Day 1 · unchanged	99 Participants	123 Participants
Change in Stool Consistency Day 8 Change in the stool consistency as compared to Day 1 · worsened	21 Participants	17 Participants
Change in Stool Consistency Day 8 Change in the stool consistency as compared to Day 1 · no data available	8 Participants	13 Participants
Change in Stool Consistency Day 9 Change in the stool consistency as compared to Day 1 · improved	75 Participants	61 Participants
Change in Stool Consistency Day 9 Change in the stool consistency as compared to Day 1 · unchanged	100 Participants	124 Participants
Change in Stool Consistency Day 9 Change in the stool consistency as compared to Day 1 · worsened	20 Participants	20 Participants
Change in Stool Consistency Day 9 Change in the stool consistency as compared to Day 1 · no data available	11 Participants	9 Participants
Change in Stool Consistency Day 10 Change in the stool consistency as compared to Day 1 · improved	74 Participants	61 Participants
Change in Stool Consistency Day 10 Change in the stool consistency as compared to Day 1 · unchanged	96 Participants	119 Participants
Change in Stool Consistency Day 10 Change in the stool consistency as compared to Day 1 · worsened	23 Participants	23 Participants
Change in Stool Consistency Day 10 Change in the stool consistency as compared to Day 1 · no data available	13 Participants	11 Participants
Change in Stool Consistency Day 11 Change in the stool consistency as compared to Day 1 · improved	83 Participants	65 Participants
Change in Stool Consistency Day 11 Change in the stool consistency as compared to Day 1 · unchanged	95 Participants	119 Participants
Change in Stool Consistency Day 11 Change in the stool consistency as compared to Day 1 · worsened	22 Participants	24 Participants
Change in Stool Consistency Day 11 Change in the stool consistency as compared to Day 1 · no data available	6 Participants	6 Participants
Change in Stool Consistency Day 12 Change in the stool consistency as compared to Day 1 · improved	80 Participants	66 Participants
Change in Stool Consistency Day 12 Change in the stool consistency as compared to Day 1 · unchanged	96 Participants	124 Participants
Change in Stool Consistency Day 12 Change in the stool consistency as compared to Day 1 · worsened	20 Participants	19 Participants
Change in Stool Consistency Day 12 Change in the stool consistency as compared to Day 1 · no data available	10 Participants	5 Participants
Change in Stool Consistency Day 13 Change in the stool consistency as compared to Day 1 · improved	76 Participants	61 Participants
Change in Stool Consistency Day 13 Change in the stool consistency as compared to Day 1 · unchanged	99 Participants	118 Participants
Change in Stool Consistency Day 13 Change in the stool consistency as compared to Day 1 · worsened	19 Participants	22 Participants
Change in Stool Consistency Day 13 Change in the stool consistency as compared to Day 1 · no data available	12 Participants	13 Participants
Change in Stool Consistency Day 14 Change in the stool consistency as compared to Day 1 · improved	81 Participants	63 Participants
Change in Stool Consistency Day 14 Change in the stool consistency as compared to Day 1 · unchanged	91 Participants	122 Participants
Change in Stool Consistency Day 14 Change in the stool consistency as compared to Day 1 · worsened	22 Participants	20 Participants
Change in Stool Consistency Day 14 Change in the stool consistency as compared to Day 1 · no data available	12 Participants	9 Participants

SECONDARY outcome

Timeframe: 14 days

The severity of gastrointestinal symptoms, including nausea, vomiting, flatulence, abdominal pain and decreased appetite was assessed based on the data of patient's diary. Severity of symptoms was assessed based on the 5-point verbal scale \[0 to 4\] where 0- symptoms were absent, 4- symptoms were very severe

Outcome measures

Outcome measures
Measure	LRG-002 n=259 Participants LRG-002 once daily for 14 days	Placebo n=259 Participants Placebo once daily for 14 days
Number of Gastrointestinal Symptoms by Severity Nausea, severity · 0. No manifestations	21 Participants	20 Participants
Number of Gastrointestinal Symptoms by Severity Nausea, severity · 1. Mild manifestations	30 Participants	21 Participants
Number of Gastrointestinal Symptoms by Severity Abdominal pain, severity · 0. No manifestations	18 Participants	19 Participants
Number of Gastrointestinal Symptoms by Severity Abdominal pain, severity · 1. Mild manifestations	29 Participants	36 Participants
Number of Gastrointestinal Symptoms by Severity Abdominal pain, severity · 2. Moderate manifestations	7 Participants	4 Participants
Number of Gastrointestinal Symptoms by Severity Abdominal pain, severity · 3. Severe manifestations	0 Participants	3 Participants
Number of Gastrointestinal Symptoms by Severity Abdominal pain, severity · No data available	205 Participants	197 Participants
Number of Gastrointestinal Symptoms by Severity Flatulence, severity · 0. No manifestations	13 Participants	13 Participants
Number of Gastrointestinal Symptoms by Severity Flatulence, severity · 1. Mild manifestations	34 Participants	50 Participants
Number of Gastrointestinal Symptoms by Severity Flatulence, severity · 2. Moderate manifestations	30 Participants	40 Participants
Number of Gastrointestinal Symptoms by Severity Flatulence, severity · 3. Severe manifestations	5 Participants	6 Participants
Number of Gastrointestinal Symptoms by Severity Flatulence, severity · No data available	177 Participants	150 Participants
Number of Gastrointestinal Symptoms by Severity Vomiting, severity · 0. No manifestations	20 Participants	21 Participants
Number of Gastrointestinal Symptoms by Severity Vomiting, severity · 1. Mild manifestations	0 Participants	2 Participants
Number of Gastrointestinal Symptoms by Severity Vomiting, severity · 2. Moderate manifestations	0 Participants	0 Participants
Number of Gastrointestinal Symptoms by Severity Vomiting, severity · 3. Severe manifestations	0 Participants	0 Participants
Number of Gastrointestinal Symptoms by Severity Vomiting, severity · No data available	239 Participants	236 Participants
Number of Gastrointestinal Symptoms by Severity Decreased appetite, severity · 0. No manifestations	11 Participants	5 Participants
Number of Gastrointestinal Symptoms by Severity Decreased appetite, severity · 1. Mild manifestations	43 Participants	51 Participants
Number of Gastrointestinal Symptoms by Severity Decreased appetite, severity · 2. Moderate manifestations	43 Participants	42 Participants
Number of Gastrointestinal Symptoms by Severity Decreased appetite, severity · 3. Severe manifestations	8 Participants	10 Participants
Number of Gastrointestinal Symptoms by Severity Decreased appetite, severity · No data available	154 Participants	151 Participants
Number of Gastrointestinal Symptoms by Severity Nausea, severity · 2. Moderate manifestations	1 Participants	2 Participants
Number of Gastrointestinal Symptoms by Severity Nausea, severity · 3. Severe manifestations	0 Participants	0 Participants
Number of Gastrointestinal Symptoms by Severity Nausea, severity · No data available	207 Participants	216 Participants

SECONDARY outcome

Timeframe: Baseline, Day 15

Change from baseline in body weight assessed based on the clinical data

Outcome measures

Outcome measures
Measure	LRG-002 n=259 Participants LRG-002 once daily for 14 days	Placebo n=257 Participants Placebo once daily for 14 days
Change From Baseline in Body Weight	0.11 Kg Standard Deviation 1.13	-0.17 Kg Standard Deviation 0.92

SECONDARY outcome

Timeframe: 14 days

Hospitalization rate was assessed based on the clinical data

Outcome measures

Outcome measures
Measure	LRG-002 n=260 Participants LRG-002 once daily for 14 days	Placebo n=260 Participants Placebo once daily for 14 days
Number of Participants Hospitalized	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 days

The number of participants using standard symptomatic therapy (as "rescue medication") to relieve symptoms of acute diarrhea were assessed based on the clinical data

Outcome measures

Outcome measures
Measure	LRG-002 n=260 Participants LRG-002 once daily for 14 days	Placebo n=260 Participants Placebo once daily for 14 days
Number of Participants Using Standard Symptomatic Therapy	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Included only 1 participants who was prescribed symptomatic therapy for C. difficile-associated diarrhea

The number of days of using standard symptomatic therapy (as "rescue medication") to relieve symptoms of acute diarrhea were assessed based on the clinical data

Outcome measures

Outcome measures
Measure	LRG-002 LRG-002 once daily for 14 days	Placebo n=1 Participants Placebo once daily for 14 days
Number of Days of Using Standard Symptomatic Therapy	—	NA Days Participant prematurely withdrawn from the trial therefore no analysis performed due to missing data

Adverse Events

LRG-002

Serious events: 0 serious events

Other events: 116 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 138 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LRG-002 n=260 participants at risk LRG-002 once daily for 14 days	Placebo n=260 participants at risk Placebo once daily for 14 days
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit	0.38% 1/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit

Other adverse events

Other adverse events
Measure	LRG-002 n=260 participants at risk LRG-002 once daily for 14 days	Placebo n=260 participants at risk Placebo once daily for 14 days
Gastrointestinal disorders Flatulence	25.0% 65/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit	34.6% 90/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit
Gastrointestinal disorders Nausea	10.8% 28/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit	7.7% 20/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit
Gastrointestinal disorders Abdominal pain	13.8% 36/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit	15.4% 40/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit
Gastrointestinal disorders Diarrhea	2.3% 6/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit	9.2% 24/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit
Metabolism and nutrition disorders Decreased appetite	35.4% 92/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit	35.8% 93/260 • Adverse events were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit Any signs or symptoms were collected throughout the study i.e until visit 3 (Day 15 ± 2) which was the treatment completion / study termination visit

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER